Zenith G32544Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10827002325446), received between Mar 16, 2016 and Mar 2, 2025 — classified as 2 deaths, 7 injuries.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

111 other recalls cover devices cleared under the same FDA submission (P020018); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• DeathMar 2, 2025Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  UNABLE TO CANNULATE THE RENAL ARTERIES THROUGH THE FENESTRATIONS. (THERE WAS SIGNIFICANT TORTUOSITY AND THROMBUS WITHIN THE VISCERAL SECTION). THE DEVICE WAS APPROPRIATELY DELIVERED AND DEPLOYED BUT THE ABILITY TO ROTATE THE DEVICE WAS MINIMAL. AFTER NUMEROUS ATTEMPTS TO CANNULATE, REPOSITION AND UTILIZING MULTIPLE TROUBLESHOOTING TECHNIQUES, THE SURGEON HAD TO PERFORM A LEFT RENAL ARTERY/EXTERNAL ILIAC BYPASS. THE RIGHT RENAL ARTERY HAD A KNOWN SUBTOTAL OSTIAL STENOSIS AND WAS NOT BYPASSED. THE ZFEN-D AND BOTH ZSLES WERE DEPLOYED WITHOUT INCIDENT." ZFEN-P-2-32-124-R LOT NUMBER AC1176074, ZFEN-D-12-28-76 LOT NUMBER AC1176077, ZSLE-16-56-ZT LOT NUMBER 15980020, ZSLE-20-74- ZT LOT NUMBER 15727540. UPDATED DESCRIPTION OF EVENT: THE DEVICE FUNCTIONED AS EXPECTED WHILE FOLLOWING THE INSTRUCTIONS FOR USE (IFU). NO DIFFICULTY WAS EXPERIENCED DURING DEPLOYMENT. THE PROXIMAL AND DISTAL FENESTRATED DEVICES WERE DEPLOYED, AS WELL AS BILATERAL ZSLE GRAFTS WITHOUT INCIDENT. DIFFICULTY WAS EXPERIENCED IN ROTATING THE DEVICE TO ALIGN THE FENESTRATIONS. THE PROXIMAL FENESTRATED DEVICE HAD BEEN ADVANCED TO THE APPROPRIATE POSITION IN THE AORTA. THE ANTERIOR/POSTERIOR MARKERS (CROSS) HAD BEEN IDENTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501323 ↗
• InjuryFeb 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  WHEN IMPLANTED, THE CASE WAS CHALLENGING AND ENDED UP WITH A TYPE 1A ENDOLEAK. THE PHYSICIAN EXPLANTED THE DEVICE APPROXIMATELY 3 WEEKS LATER.

  Patient problems: Clinical Endoleak

  MAUDE report 16417258 ↗
• InjuryFeb 12, 2023Leak/Splash; Activation Failure; Activation Failure

  WHEN IMPLANTED, THE CASE WAS CHALLENGING AND ENDED UP WITH A TYPE 1A ENDOLEAK. THE PHYSICIAN EXPLANTED THE DEVICE APPROXIMATELY 3 WEEKS LATER.

  Patient problems: Clinical Endoleak

  MAUDE report 16360044 ↗
• InjuryJul 17, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  FINAL ANGIO SHOWED AN ENDOLEAK DISTAL TO PROXIMAL & DISTAL BODY OVERLAP. DRS. USED A CODA BALLOON TO HELP SEAL PROXIMAL AND DISTAL BODY OVER LAP (ABOUT 3.5 STENT OVERLAP) & THEN DID ANOTHER ANGIO. THE LEAK WAS STILL THERE. DRS. INFLATED 32 CODA BALLOON IN OVERLAP OF THE PROXIMAL & DISTAL BODY AND PLACED A PIGTAIL MARKER JUST DISTAL TO THE OVERLAP (UP THE CONTRA SIDE - LEFT ILIAC) AND DID AN ANGIO TO SEE IF THERE WAS STILL A LEAK. THE ENDOLEAK WAS NOT COMING FROM THE PROXIMAL & DISTAL BODY OVERLAP, IT LOOKS LIKE IT IS COMING FROM A HOLE OR TEAR IN THE DISTAL PANTS, JUST PROXIMAL TO THE CONTRA LIMB OVERLAP. DRS. PLACED AN ESBE TO HELP SEAL ENDOLEAK. IT LOOKS LIKE A SMALL LEAK IS STILL THERE. DRS. PLAN TO RESCAN PATIENT IN THE NEXT 30 DAYS OR SO TO SEE IF THE LEAK HAS SEALED OFF.

  Patient problems: No Code Available

  MAUDE report 10288195 ↗
• InjuryAug 15, 2018Leak/Splash; Material Separation

  ON (B)(6) 2018, THE PATIENT PRESENTED WITH A CONTAINED RUPTURE DUE TO A TYPE 3 ENDOLEAK OF COMPONENT SEPARATION. THE PROXIMAL AND DISTAL PIECES WERE SEPARATED. THE PATIENT WAS TREATED WITH AN ABDOMINAL 28 MM CUFF TO BRIDGE THE TWO COMPONENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 7787433 ↗
• InjuryJul 19, 2017Sticking

  THE PRE-LOADED WIRE WAS STUCK IN THE PRE-LOADED CATHETER WHEN ATTEMPTING TO REMOVE. ADDITIONAL INFORMATION: WILLIAM COOK (B)(4) INITIALLY REPORTED THIS EVENT BASED ON AVAILABLE INFORMATION AT THE TIME OF COMPLAINT REGISTRATION. NEW INFORMATION WAS PROVIDED IDENTIFYING THAT THE PRODUCT WAS ACTUALLY A COOK INC. MANUFACTURED DEVICE. REPORT REFERENCE 1820334-2017-02718 WAS SUBMITTED BY COOK INC ON THE 22 AUGUST 17.

  Patient problems: No Information

  MAUDE report 6727257 ↗
• InjuryJul 19, 2017Leak/Splash

  DELIVERY SYSTEM BEGAN LEAKING EXTENSIVELY AT THE WHITE PLASTIC ASSEMBLY WHERE THE TRIGGER WIRE RELEASE ARE MOUNTED. PATIENT LOST EXTENSIVE AMOUNT OF BLOOD AND PRESSURE CRASHED. IT WAS ATTEMPTED TO REDUCE BLOOD LOSS FROM LEAKING AREA, DRUGS WAS ADMINISTERED TO INCREASE BLOOD PRESSURE AND AN OCCLUSION BALLOON WAS REPEATEDLY INFLATED & DEFLATED TO OCCLUDE AORTA. PATIENT LOST 1.5 LITERS OF BLOOD. 07 AUGUST 17 UPDATE: PATIENT LOST 2.7 LITERS OF BLOOD AND WAS NEAR CARDIAC ARREST. THE PATIENT ANATOMY WAS TECHNICALLY EASY AND THE ENDOVASCULAR SEGMENT WAS ABLE TO BE COMPLETE IN 20 MINUTES UNTIL THE DELIVERY SYSTEM COULD BE EXCHANGED.

  Patient problems: Blood Loss; Dyspnea

  MAUDE report 6727201 ↗
• DeathFeb 9, 2017Material Separation

  THE PATIENT HAD A RUPTURED ANEURYSM FROM A TYPE 3 ENDOLEAK CAUSED BY GRAFT SEPARATION. THE PATIENT EXPIRED ON (B)(6) 2017 AT (B)(6) HOSPITAL EMERGENCY ROOM. THE PROXIMAL FENESTRATED GRAFT AND THE DISTAL BIFURCATED GRAFT LOST THEIR OVERLAP AND THE TWO GRAFTS SEPARATED. THE DEVICES WERE INITIALLY IMPLANTED ON THE (B)(6) 2013 AT (B)(6).

  Patient problems: Aneurysm; Death; Rupture

  MAUDE report 6319398 ↗
• InjuryMar 16, 2016Adverse Event Without Identified Device or Use Problem

  THE LARGE FENESTRATION FOR THE SMA (SUPERIOR MESENTERIC ARTERY) VESSEL ENDED UP POSTERIOR INSTEAD OF ANTERIOR ON FINAL ANGIO.THE GRAFT WAS PROPERLY ORIENTED BY PHYSICIAN AND DM PRIOR TO IMPLANT. AN ADDITIONAL STENT WAS PLACED IN THE SMA THAT EXTENDED ABOVE FIXATION STENT.

  Patient problems: No Code Available

  MAUDE report 5506113 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020018. One submission often covers many models, so check the product and lot details in each record.

• Z-3145-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-56-ZT, REF G48465, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3152-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-73-ZT, REF G48476, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3158-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-32-39, REF G32184, 20 Fr. ID/ 7.7 mm OD, Sterile.
• Z-3157-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-30-39, REF G32183, 20 Fr. ID/ 7.7 OD, Sterile.
• Z-3144-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-90-ZT, REF G48463, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3137-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-32-96-ZT, REF G48428, 20 Fr ID/ 7.7 mm OD, Sterile.
• Z-3154-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-24-73-ZT, REF G48478, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3133-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-26-125-ZT, REF G48415, 18 Fr ID/ 7.1 mm OD, Sterile.
• Z-3141-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-14-56-ZT, REF G48455, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3156-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-22-29, REF G32179, 18 Fr. ID/ 6.90 OD, Sterile.
• Z-3130-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-24-82-ZT, REF G48407, 18 Fr ID/ 7.1 mm OD, Sterile
• Z-3136-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-32-82-ZT, REF G48427, 20 Fr ID/ 7.7 mm OD, Sterile.
• Z-3139-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-10-71-ZT, REF G48444, 14 Fr ID/ 5.3 mm OD, Sterile.
• Z-3131-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-24-96-ZT, REF G48408, 18 Fr ID/ 7.1 mm OD, Sterile
• Z-3153-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48477, 16Fr ID/ 6.0 mm OD, Sterile.

…and 96 more.